BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROLENE BLUE 0.7M 60CM W/NDL

    MDR report key: 9821169 · Received March 11, 2020

    Report

    Report Number
    2210968-2020-01961
    Event Type
    Malfunction
    Date Received
    March 11, 2020
    Report Date
    February 17, 2020
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DATE SENT TO THE FDA: 04/21/2020. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. ADDITIONAL H-3 SUMMARY: REPRESENTATIVE SAMPLES: EIGHTEEN UNOPENED SAMPLES OF PRODUCT CODE W8704, LOT PEH715 RECEIVED FOR EVALUATION. THE COMPLAINT SAMPLE WAS NOT RETURNED FOR EVALUATION. DURING THE VISUAL INSPECTION OF THIRTEEN UNOPENED SAMPLES, NO DEFECTS WERE FOUND ON THE PACKAGES. THE SAMPLES WERE OPENED, AND THE SWAGE AND ATTACHMENT AREA WERE NOTED TO BE AS EXPECTED. THE SUTURES WERE DISPENSED WITHOUT PROBLEMS AND EXAMINED ALONG OF THE STRAND AND NO DEFECTS, DAMAGED OR SUTURE BREAKAGE WERE NOTED. A FUNCTIONAL TEST WAS PERFORMED USING AN INSTRON AND THE TENSILE STRENGTH FORCE WAS ABOVE THE MINIMUM REQUIREMENT. PER THE CONDITION OF THE SAMPLES RECEIVED, NO PERFORMANCE - BREAKAGE SUTURE WAS FOUND AND THE TESTED SAMPLES MET THE FINISHED GOODS REQUIREMENTS. FROM OTHER LOTS (NOT REPORTED IN THE EVENT): SIX UNOPENED SAMPLES OF LOT MGE045, THREE UNOPENED SAMPLES OF LOT MHH339, TWO UNOPENED SAMPLES OF LOT MEH679, TWO UNOPENED SAMPLES OF LOT PAJ773 AND AN UNOPENED SAMPLE OF LOT PCQ270 WERE RECEIVED FOR EVALUATION. DURING THE VISUAL INSPECTION OF UNOPENED SAMPLES, NO DEFECTS WERE FOUND ON THE PACKAGES. THE SAMPLES WERE OPENED, AND THE SWAGE AND ATTACHMENT AREA WERE NOTED TO BE AS EXPECTED. THE SUTURES WERE DISPENSED WITHOUT PROBLEMS AND EXAMINED ALONG OF THE STRAND AND NO DEFECTS, DAMAGED OR SUTURE BREAKAGE WERE NOTED. A FUNCTIONAL TEST WAS PERFORMED USING AN INSTRON AND THE TENSILE STRENGTH FORCE WAS ABOVE THE MINIMUM REQUIREMENT. THE MANUFACTURING RECORDS WERE REVIEWED FOR ALL LOTS AND THE MANUFACTURING/PACKAGING CRITERIA WERE MET PRIOR TO THE RELEASE OF THIS BATCH. PER THE CONDITION OF THE SAMPLES RECEIVED, NO PERFORMANCE - BREAKAGE SUTURE WAS FOUND AND THE TESTED SAMPLES MET THE FINISHED GOODS REQUIREMENTS. EVENTS WERE SUBMITTED VIA 2210968-2020-01951, 2210968-2020-01953, 2210968-2020-01955, 2210968-2020-01956, 2210968-2020-01960, 2210968-2020-01961, 2210968-2020-01963, 2210968-2020-01965, 2210968-2020-01966, 2210968-2020-01967, 2210968-2020-01969, 2210968-2020-01970, 2210968-2020-01971, 2210968-2020-01972, 2210968-2020-01973 AND 2210968-2020-01974.

    Additional Manufacturer Narrative · 1

    (B)(4). ATTEMPTS ARE BEING MADE TO OBTAIN DEVICE RETURN FOR EVALUATION. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT THE LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. WAS PROCEDURE SUCCESSFULLY COMPLETED WITHOUT ANY PATIENT CONSEQUENCE? WAS THERE ANY SURGICAL OR MEDICAL INTERVENTION REQUIRED FOR THE SURGEON? SAMPLE RETURN STATUS?

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SHUNT PROCEDURE IN 2020 AND THE SUTURE WAS USED. IT WAS REPORTED THAT DURING SUTURING IN SHUNT PATIENT, THE SUTURE CONTINUE BROKEN AND PATIENT¿S BLOOD SPRAY SURGEON¿S FACE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281163 PROLENE BLUE 0.7M 60CM W/NDL SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC. PEH715

    Patients

    Seq Age Sex Outcome Treatment
    1